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Importance: The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated. Observations: Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure. Conclusions and Relevance: We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal. This Special Communication proposes expanding clinical research to include rigorous evaluation of multiple data sources and types and to enable reuse of health data for many purposes to produce evidence about medical interventions. [ABSTRACT FROM AUTHOR]

Key Points: Question: How many excess deaths and years of potential life lost for the Black population, compared with the White population, occurred in the United States from 1999 through 2020? Findings: Based on Centers for Disease Control and Prevention data, excess deaths and years of potential life lost persisted throughout the period, with initial progress followed by stagnation of improvement and substantial worsening in 2020. The Black population had 1.63 million excess deaths, representing more than 80 million years of potential life lost over the study period. Meaning: After initial progress, excess mortality and years of potential life lost among the US Black population stagnated and then worsened, indicating a need for new approaches. Importance: Amid efforts in the US to promote health equity, there is a need to assess recent progress in reducing excess deaths and years of potential life lost among the Black population compared with the White population. Objective: To evaluate trends in excess mortality and years of potential life lost among the Black population compared with the White population. Design, setting, and participants: Serial cross-sectional study using US national data from the Centers for Disease Control and Prevention from 1999 through 2020. We included data from non-Hispanic White and non-Hispanic Black populations across all age groups. Exposures: Race as documented in the death certificates. Main outcomes and measures: Excess age-adjusted all-cause mortality, cause-specific mortality, age-specific mortality, and years of potential life lost rates (per 100 000 individuals) among the Black population compared with the White population. Results: From 1999 to 2011, the age-adjusted excess mortality rate declined from 404 to 211 excess deaths per 100 000 individuals among Black males (P for trend <.001). However, the rate plateaued from 2011 through 2019 (P for trend =.98) and increased in 2020 to 395—rates not seen since 2000. Among Black females, the rate declined from 224 excess deaths per 100 000 individuals in 1999 to 87 in 2015 (P for trend <.001). There was no significant change between 2016 and 2019 (P for trend =.71) and in 2020 rates increased to 192—levels not seen since 2005. The trends in rates of excess years of potential life lost followed a similar pattern. From 1999 to 2020, the disproportionately higher mortality rates in Black males and females resulted in 997 623 and 628 464 excess deaths, respectively, representing a loss of more than 80 million years of life. Heart disease had the highest excess mortality rates, and the excess years of potential life lost rates were largest among infants and middle-aged adults. Conclusions and relevance: Over a recent 22-year period, the Black population in the US experienced more than 1.63 million excess deaths and more than 80 million excess years of life lost when compared with the White population. After a period of progress in reducing disparities, improvements stalled, and differences between the Black population and the White population worsened in 2020. This study focuses on differences in mortality and years of potential life lost between Black and White populations to understand recent trends. [ABSTRACT FROM AUTHOR]

Key Points: Question: When medical devices that had been cleared under the FDA's 510(k) pathway are subject to Class I recalls, how often did the predicates for these devices also have a history of recalls? Findings: In this cross-sectional analysis of 156 cases of 510(k)–authorized devices with Class I recalls from 2017 through 2021, 44.1% used predicates with Class I recalls. In addition, 48.1% of these devices were subsequently used as predicates to authorize descendant devices later subject to Class I recalls. The risk of a Class I recall was 6.40 times higher for descendants that used predicates with Class I recalls than for devices using Class I recall–free predicates. Meaning: Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety. Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall—the FDA's most serious designation indicating a high probability of adverse health consequences or death—as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety. This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall. [ABSTRACT FROM AUTHOR]

Importance: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade.Objective: To determine the change in the rate of adverse events in hospitalized patients.Design, Setting, and Participants: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%).Exposures: Adults aged 18 years or older hospitalized during each included calendar year.Main Outcomes and Measures: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations.Results: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly.Conclusions and Relevance: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety. [ABSTRACT FROM AUTHOR]

This study describes the degree to which blood draws occurred among hospitalized patients during traditional sleep hours and investigates trends over time. [ABSTRACT FROM AUTHOR]

Importance: The elimination of racial and ethnic differences in health status and health care access is a US goal, but it is unclear whether the country has made progress over the last 2 decades.Objective: To determine 20-year trends in the racial and ethnic differences in self-reported measures of health status and health care access and affordability among adults in the US.Design, Setting, and Participants: Serial cross-sectional study of National Health Interview Survey data, 1999-2018, that included 596 355 adults.Exposures: Self-reported race, ethnicity, and income level.Main Outcomes and Measures: Rates and racial and ethnic differences in self-reported health status and health care access and affordability.Results: The study included 596 355 adults (mean [SE] age, 46.2 [0.07] years, 51.8% [SE, 0.10] women), of whom 4.7% were Asian, 11.8% were Black, 13.8% were Latino/Hispanic, and 69.7% were White. The estimated percentages of people with low income were 28.2%, 46.1%, 51.5%, and 23.9% among Asian, Black, Latino/Hispanic, and White individuals, respectively. Black individuals with low income had the highest estimated prevalence of poor or fair health status (29.1% [95% CI, 26.5%-31.7%] in 1999 and 24.9% [95% CI, 21.8%-28.3%] in 2018), while White individuals with middle and high income had the lowest (6.4% [95% CI, 5.9%-6.8%] in 1999 and 6.3% [95% CI, 5.8%-6.7%] in 2018). Black individuals had a significantly higher estimated prevalence of poor or fair health status than White individuals in 1999, regardless of income strata (P < .001 for the overall and low-income groups; P = .03 for middle and high-income group). From 1999 to 2018, racial and ethnic gaps in poor or fair health status did not change significantly, with or without income stratification, except for a significant decrease in the difference between White and Black individuals with low income (-6.7 percentage points [95% CI, -11.3 to -2.0]; P = .005); the difference in 2018 was no longer statistically significant (P = .13). Black and White individuals had the highest levels of self-reported functional limitations, which increased significantly among all groups over time. There were significant reductions in the racial and ethnic differences in some self-reported measures of health care access, but not affordability, with and without income stratification.Conclusions and Relevance: In a serial cross-sectional survey study of US adults from 1999 to 2018, racial and ethnic differences in self-reported health status, access, and affordability improved in some subgroups, but largely persisted. [ABSTRACT FROM AUTHOR]

This modeling study estimates the excess deaths attributable to COVID-19 disease in Massachusetts during the Delta (June to December 2021) and Omicron (December 2021 to February 2022) waves. [ABSTRACT FROM AUTHOR]

Importance: Current guidelines recommend ticagrelor as the preferred P2Y12 platelet inhibitor for patients with acute coronary syndrome (ACS), primarily based on a single large randomized clinical trial. The benefits and risks associated with ticagrelor vs clopidogrel in routine practice merits attention.Objective: To determine the association of ticagrelor vs clopidogrel with ischemic and hemorrhagic events in patients undergoing percutaneous coronary intervention (PCI) for ACS in clinical practice.Design, Setting, and Participants: A retrospective cohort study of patients with ACS who underwent PCI and received ticagrelor or clopidogrel was conducted using 2 United States electronic health record-based databases and 1 nationwide South Korean database from November 2011 to March 2019. Patients were matched using a large-scale propensity score algorithm, and the date of final follow-up was March 2019.Exposures: Ticagrelor vs clopidogrel.Main Outcomes and Measures: The primary end point was net adverse clinical events (NACE) at 12 months, composed of ischemic events (recurrent myocardial infarction, revascularization, or ischemic stroke) and hemorrhagic events (hemorrhagic stroke or gastrointestinal bleeding). Secondary outcomes included NACE or mortality, all-cause mortality, ischemic events, hemorrhagic events, individual components of the primary outcome, and dyspnea at 12 months. The database-level hazard ratios (HRs) were pooled to calculate summary HRs by random-effects meta-analysis.Results: After propensity score matching among 31 290 propensity-matched pairs (median age group, 60-64 years; 29.3% women), 95.5% of patients took aspirin together with ticagrelor or clopidogrel. The 1-year risk of NACE was not significantly different between ticagrelor and clopidogrel (15.1% [3484/23 116 person-years] vs 14.6% [3290/22 587 person-years]; summary HR, 1.05 [95% CI, 1.00-1.10]; P = .06). There was also no significant difference in the risk of all-cause mortality (2.0% for ticagrelor vs 2.1% for clopidogrel; summary HR, 0.97 [95% CI, 0.81-1.16]; P = .74) or ischemic events (13.5% for ticagrelor vs 13.4% for clopidogrel; summary HR, 1.03 [95% CI, 0.98-1.08]; P = .32). The risks of hemorrhagic events (2.1% for ticagrelor vs 1.6% for clopidogrel; summary HR, 1.35 [95% CI, 1.13-1.61]; P = .001) and dyspnea (27.3% for ticagrelor vs 22.6% for clopidogrel; summary HR, 1.21 [95% CI, 1.17-1.26]; P < .001) were significantly higher in the ticagrelor group.Conclusions and Relevance: Among patients with ACS who underwent PCI in routine clinical practice, ticagrelor, compared with clopidogrel, was not associated with significant difference in the risk of NACE at 12 months. Because the possibility of unmeasured confounders cannot be excluded, further research is needed to determine whether ticagrelor is more effective than clopidogrel in this setting. [ABSTRACT FROM AUTHOR]

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice.Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017.Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only.Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding.Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI.Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients. [ABSTRACT FROM AUTHOR]

This study uses national death certificate data to characterize trends in death and excess mortality from drug overdoses, homicides, unintentional injuries, motor vehicle crashes, and suicide during the first 6 months of the pandemic in the US. [ABSTRACT FROM AUTHOR]

This study compares all-cause excess mortality and COVID-19–related mortality during the early pandemic period (March-July 2020) with unintentional drug overdoses, the usual leading cause of death in young adults, during the same period in 2018 among adults aged 25 to 44 years. [ABSTRACT FROM AUTHOR]

This study describes submissions, postings, abstract views, downloads, comments, and withdrawals on the medRxiv preprint server from June 2019 to June 2020 and compares submissions and postings before and after COVID-19. [ABSTRACT FROM AUTHOR]

Importance: Publicly available data sets hold much potential, but their unique design may require specific analytic approaches.Objective: To determine adherence to appropriate research practices for a frequently used large public database, the National Inpatient Sample (NIS) of the Agency for Healthcare Research and Quality (AHRQ).Design, Setting, and Participants: In this observational study of the 1082 studies published using the NIS from January 2015 through December 2016, a representative sample of 120 studies was systematically evaluated for adherence to practices required by AHRQ for the design and conduct of research using the NIS.Exposures: None.Main Outcomes and Measures: All studies were evaluated on 7 required research practices based on AHRQ's recommendations and compiled under 3 domains: (1) data interpretation (interpreting data as hospitalization records rather than unique patients); (2) research design (avoiding use in performing state-, hospital-, and physician-level assessments where inappropriate; not using nonspecific administrative secondary diagnosis codes to study in-hospital events); and (3) data analysis (accounting for complex survey design of the NIS and changes in data structure over time).Results: Of 120 published studies, 85% (n = 102) did not adhere to 1 or more required practices and 62% (n = 74) did not adhere to 2 or more required practices. An estimated 925 (95% CI, 852-998) NIS publications did not adhere to 1 or more required practices and 696 (95% CI, 596-796) NIS publications did not adhere to 2 or more required practices. A total of 79 sampled studies (68.3% [95% CI, 59.3%-77.3%]) among the 1082 NIS studies screened for eligibility did not account for the effects of sampling error, clustering, and stratification; 62 (54.4% [95% CI, 44.7%-64.0%]) extrapolated nonspecific secondary diagnoses to infer in-hospital events; 45 (40.4% [95% CI, 30.9%-50.0%]) miscategorized hospitalizations as individual patients; 10 (7.1% [95% CI, 2.1%-12.1%]) performed state-level analyses; and 3 (2.9% [95% CI, 0.0%-6.2%]) reported physician-level volume estimates. Of 27 studies (weighted; 218 studies [95% CI, 134-303]) spanning periods of major changes in the data structure of the NIS, 21 (79.7% [95% CI, 62.5%-97.0%]) did not account for the changes. Among the 24 studies published in journals with an impact factor of 10 or greater, 16 (67%) did not adhere to 1 or more practices, and 9 (38%) did not adhere to 2 or more practices.Conclusions and Relevance: In this study of 120 recent publications that used data from the NIS, the majority did not adhere to required practices. Further research is needed to identify strategies to improve the quality of research using the NIS and assess whether there are similar problems with use of other publicly available data sets. [ABSTRACT FROM AUTHOR]

Importance: The Affordable Care Act has led to US national reductions in hospital 30-day readmission rates for heart failure (HF), acute myocardial infarction (AMI), and pneumonia. Whether readmission reductions have had the unintended consequence of increasing mortality after hospitalization is unknown.Objective: To examine the correlation of paired trends in hospital 30-day readmission rates and hospital 30-day mortality rates after discharge.Design, Setting, and Participants: Retrospective study of Medicare fee-for-service beneficiaries aged 65 years or older hospitalized with HF, AMI, or pneumonia from January 1, 2008, through December 31, 2014.Exposure: Thirty-day risk-adjusted readmission rate (RARR).Main Outcomes and Measures: Thirty-day RARRs and 30-day risk-adjusted mortality rates (RAMRs) after discharge were calculated for each condition in each month at each hospital in 2008 through 2014. Monthly trends in each hospital's 30-day RARRs and 30-day RAMRs after discharge were examined for each condition. The weighted Pearson correlation coefficient was calculated for hospitals' paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge for each condition.Results: In 2008 through 2014, 2 962 554 hospitalizations for HF, 1 229 939 for AMI, and 2 544 530 for pneumonia were identified at 5016, 4772, and 5057 hospitals, respectively. In January 2008, mean hospital 30-day RARRs and 30-day RAMRs after discharge were 24.6% and 8.4% for HF, 19.3% and 7.6% for AMI, and 18.3% and 8.5% for pneumonia. Hospital 30-day RARRs declined in the aggregate across hospitals from 2008 through 2014; monthly changes in RARRs were -0.053% (95% CI, -0.055% to -0.051%) for HF, -0.044% (95% CI, -0.047% to -0.041%) for AMI, and -0.033% (95% CI, -0.035% to -0.031%) for pneumonia. In contrast, monthly aggregate changes across hospitals in hospital 30-day RAMRs after discharge varied by condition: HF, 0.008% (95% CI, 0.007% to 0.010%); AMI, -0.003% (95% CI, -0.005% to -0.001%); and pneumonia, 0.001% (95% CI, -0.001% to 0.003%). However, correlation coefficients in hospitals' paired monthly changes in 30-day RARRs and 30-day RAMRs after discharge were weakly positive: HF, 0.066 (95% CI, 0.036 to 0.096); AMI, 0.067 (95% CI, 0.027 to 0.106); and pneumonia, 0.108 (95% CI, 0.079 to 0.137). Findings were similar in secondary analyses, including with alternate definitions of hospital mortality.Conclusions and Relevance: Among Medicare fee-for-service beneficiaries hospitalized for heart failure, acute myocardial infarction, or pneumonia, reductions in hospital 30-day readmission rates were weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge. These findings do not support increasing postdischarge mortality related to reducing hospital readmissions. [ABSTRACT FROM AUTHOR]

Importance: Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making.Objectives: To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk.Design and Setting: Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017.Exposures: Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time.Main Outcomes and Measures: A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications.Results: From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02).Conclusions and Relevance: Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle. [ABSTRACT FROM AUTHOR]

Importance: Readmission rates declined after announcement of the Hospital Readmission Reduction Program (HRRP), which penalizes hospitals for excess readmissions for acute myocardial infarction (AMI), heart failure (HF), and pneumonia.Objective: To compare trends in readmission rates for target and nontarget conditions, stratified by hospital penalty status.Design, Setting, and Participants: Retrospective cohort study of Medicare fee-for-service beneficiaries older than 64 years discharged between January 1, 2008, and June 30, 2015, from 2214 penalty hospitals and 1283 nonpenalty hospitals. Difference-interrupted time-series models were used to compare trends in readmission rates by condition and penalty status.Exposure: Hospital penalty status or target condition under the HRRP.Main Outcomes and Measures: Thirty-day risk adjusted, all-cause unplanned readmission rates for target and nontarget conditions.Results: The study included 48 137 102 hospitalizations of 20 351 161 Medicare beneficiaries. In January 2008, the mean readmission rates for AMI, HF, pneumonia, and nontarget conditions were 21.9%, 27.5%, 20.1%, and 18.4%, respectively, at hospitals later subject to financial penalties and 18.7%, 24.2%, 17.4%, and 15.7% at hospitals not subject to penalties. Between January 2008 and March 2010, prior to HRRP announcement, readmission rates were stable across hospitals (except AMI at nonpenalty hospitals). Following announcement of HRRP (March 2010), readmission rates for both target and nontarget conditions declined significantly faster for patients at hospitals later subject to financial penalties compared with those at nonpenalized hospitals (for AMI, additional decrease of -1.24 [95% CI, -1.84 to -0.65] percentage points per year relative to nonpenalty discharges; for HF, -1.25 [95% CI, -1.64 to -0.86]; for pneumonia, -1.37 [95% CI, -1.80 to -0.95]; and for nontarget conditions, -0.27 [95% CI, -0.38 to -0.17]; P < .001 for all). For penalty hospitals, readmission rates for target conditions declined significantly faster compared with nontarget conditions (for AMI, additional decline of -0.49 [95% CI, -0.81 to -0.16] percentage points per year relative to nontarget conditions [P = .004]; for HF, -0.90 [95% CI, -1.18 to -0.62; P < .001]; and for pneumonia, -0.57 [95% CI, -0.92 to -0.23; P < .001]). In contrast, among nonpenalty hospitals, readmissions for target conditions declined similarly or more slowly compared with nontarget conditions (for AMI, additional increase of 0.48 [95% CI, 0.01-0.95] percentage points per year [P = .05]; for HF, 0.08 [95% CI, -0.30 to 0.46; P = .67]; for pneumonia, 0.53 [95% CI, 0.13-0.93; P = .01]). After HRRP implementation in October 2012, the rate of change for readmission rates plateaued (P < .05 for all except pneumonia at nonpenalty hospitals), with the greatest relative change observed among hospitals subject to financial penalty.Conclusions and Relevance: Medicare fee-for-service patients at hospitals subject to penalties under the HRRP had greater reductions in readmission rates compared with those at nonpenalized hospitals. Changes were greater for target vs nontarget conditions for patients at the penalized hospitals but not at the other hospitals. [ABSTRACT FROM AUTHOR]

This study uses Medicare billing codes to characterize trends in readmission and mortality rates for Medicare fee-for-service beneficiaries with pulmonary embolism (PE) between 1999 and 2015 to assess changes accompanying recent diagnostic and therapeutic changes in management of the disease. [ABSTRACT FROM AUTHOR]

Importance: Little contemporary information is available about comparative performance between Veterans Affairs (VA) and non-VA hospitals, particularly related to mortality and readmission rates, 2 important outcomes of care.Objective: To assess and compare mortality and readmission rates among men in VA and non-VA hospitals.Design, Setting, and Participants: Cross-sectional analysis involving male Medicare fee-for-service beneficiaries aged 65 years or older hospitalized between 2010 and 2013 in VA and non-VA acute care hospitals for acute myocardial infarction (AMI), heart failure (HF), or pneumonia using the Medicare Standard Analytic Files and Enrollment Database together with VA administrative claims data. To avoid confounding geographic effects with health care system effects, we studied VA and non-VA hospitals within the same metropolitan statistical area (MSA).Exposures: Hospitalization in a VA or non-VA hospital in MSAs that contained at least 1 VA and non-VA hospital.Main Outcomes and Measures: For each condition, 30-day risk-standardized mortality rates and risk-standardized readmission rates for VA and non-VA hospitals. Mean aggregated within-MSA differences in mortality and readmission rates were also assessed.Results: We studied 104 VA and 1513 non-VA hospitals, with each condition-outcome analysis cohort for VA and non-VA hospitals containing at least 7900 patients (men; ≥65 years), in 92 MSAs. Mortality rates were lower in VA hospitals than non-VA hospitals for AMI (13.5% vs 13.7%, P = .02; -0.2 percentage-point difference) and HF (11.4% vs 11.9%, P = .008; -0.5 percentage-point difference), but higher for pneumonia (12.6% vs 12.2%, P = .045; 0.4 percentage-point difference). In contrast, readmission rates were higher in VA hospitals for all 3 conditions (AMI, 17.8% vs 17.2%, 0.6 percentage-point difference; HF, 24.7% vs 23.5%, 1.2 percentage-point difference; pneumonia, 19.4% vs 18.7%, 0.7 percentage-point difference, all P < .001). In within-MSA comparisons, VA hospitals had lower mortality rates for AMI (percentage-point difference, -0.22; 95% CI, -0.40 to -0.04) and HF (-0.63; 95% CI, -0.95 to -0.31), and mortality rates for pneumonia were not significantly different (-0.03; 95% CI, -0.46 to 0.40); however, VA hospitals had higher readmission rates for AMI (0.62; 95% CI, 0.48 to 0.75), HF (0.97; 95% CI, 0.59 to 1.34), or pneumonia (0.66; 95% CI, 0.41 to 0.91).Conclusions and Relevance: Among older men with AMI, HF, or pneumonia, hospitalization at VA hospitals, compared with hospitalization at non-VA hospitals, was associated with lower 30-day risk-standardized all-cause mortality rates for AMI and HF, and higher 30-day risk-standardized all-cause readmission rates for all 3 conditions, both nationally and within similar geographic areas, although absolute differences between these outcomes at VA and non-VA hospitals were small. [ABSTRACT FROM AUTHOR]

Importance: Appropriate Use Criteria for Coronary Revascularization were developed to critically evaluate and improve patient selection for percutaneous coronary intervention (PCI). National trends in the appropriateness of PCI have not been examined.Objective: To examine trends in PCI utilization, patient selection, and procedural appropriateness following the introduction of Appropriate Use Criteria.Design, Setting, and Participants: Multicenter, longitudinal, cross-sectional analysis of patients undergoing PCI between July 1, 2009, and December 31, 2014, at hospitals continuously participating in the National Cardiovascular Data Registry CathPCI registry over the study period.Main Outcomes and Measures: Proportion of nonacute PCIs classified as inappropriate at the patient and hospital level using the 2012 Appropriate Use Criteria for Coronary Revascularization.Results: A total of 2.7 million PCI procedures from 766 hospitals were included. Annual PCI volume of acute indications was consistent over the study period (377,540 in 2010; 374,543 in 2014), but the volume of nonacute PCIs decreased from 89,704 in 2010 to 59,375 in 2014. Among patients undergoing nonacute PCI, there were significant increases in angina severity (Canadian Cardiovascular Society grade III/IV angina, 15.8% in 2010 and 38.4% in 2014), use of antianginal medications prior to PCI (at least 2 antianginal medications, 22.3% in 2010 and 35.1% in 2014), and high-risk findings on noninvasive testing (22.2% in 2010 and 33.2% in 2014) (P < .001 for all), but only modest increases in multivessel coronary artery disease (43.7% in 2010 and 47.5% in 2014, P < .001). The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% (95% CI, 25.8%-26.6%) to 13.3% (95% CI, 13.1%-13.6%), and the absolute number of inappropriate PCIs decreased from 21,781 to 7921. Hospital-level variation in the proportion of PCIs classified as inappropriate persisted over the study period (median, 12.6% [interquartile range, 5.9%-22.9%] in 2014).Conclusions and Relevance: Since the publication of the Appropriate Use Criteria for Coronary Revascularization in 2009, there have been significant reductions in the volume of nonacute PCI. The proportion of nonacute PCIs classified as inappropriate has declined, although hospital-level variation in inappropriate PCI persists. [ABSTRACT FROM AUTHOR]

IMPORTANCE The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. OBJECTIVE To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. DESIGN AND SETTING All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. MAIN OUTCOMES AND MEASURES Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. RESULTS In 2010 and 2011.28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies. 30 (10.5%) pivotal premarket studies. 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR. 119-640), and 250 patients (IQR. 60-800) for nonpivotal premarket, pivotal. FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]: ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR. 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. CONCLUSIONS AND RELEVANCE Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval. [ABSTRACT FROM AUTHOR]

IMPORTANCE In a period of dynamic change in health care technology, delivery, and behaviors, tracking trends in health and health care can provide a perspective on what is being achieved. OBJECTIVE To comprehensively describe national trends in mortality, hospitalizations, and expenditures in the Medicare fee-for-service population between 1999 and 2013. DESIGN, SETTING, AND PARTICIPANTS Serial cross-sectional analysis of Medicare beneficiaries aged 65 years or older between 1999 and 2013 using Medicare denominator and inpatient files. MAIN OUTCOMES AND MEASURES For all Medicare beneficiaries, trends in all-cause mortality; for fee-for-service beneficiaries, trends in all-cause hospitalization and hospitalization-associated outcomes and expenditures. Geographic variation, stratified by key demographic groups, and changes in the intensity of care for fee-for-service beneficiaries in the last 1, 3, and 6 months of life were also assessed. RESULTS The sample consisted of 68 374 904 unique Medicare beneficiaries (fee-for-service and Medicare Advantage). All-cause mortality for all Medicare beneficiaries declined from 5.30% in 1999 to 4.45% in 2013 (difference, 0.85 percentage points; 95% CI, 0.83-0.87). Among fee-for-service beneficiaries (n = 60 056 069), the total number of hospitalizations per 100 000 person-years decreased from 35 274 to 26 930 (difference, 8344; 95% CI, 8315-8374). Mean inflation-adjusted inpatient expenditures per Medicare fee-for-service beneficiary declined from $3290 to $2801 (difference, $489; 95% CI, $487-$490). Among fee-for-service beneficiaries in the last 6 months of life, the number of hospitalizations decreased from 131.1 to 102.9 per 100 deaths (difference, 28.2; 95% CI, 27.9-28.4). The percentage of beneficiaries with 1 or more hospitalizations decreased from 70.5 to 56.8 per 100 deaths (difference, 13.7; 95% CI, 13.5-13.8), while the inflation-adjusted inpatient expenditure per death increased from $15 312 in 1999 to $17 423 in 2009 and then decreased to $13 388 in 2013. Findings were consistent across geographic and demographic groups. CONCLUSIONS AND RELEVANCE Among Medicare fee-for-service beneficiaries aged 65 years or older, all-cause mortality rates, hospitalization rates, and expenditures per beneficiary decreased from 1999 to 2013. In the last 6 months of life, total hospitalizations and inpatient expenditures decreased in recent years. [ABSTRACT FROM AUTHOR]

This Viewpoint considers the barriers to efficient medical record keeping and suggests ways the systems can be studied to maximize their promise and minimize the undue burden many physicians shoulder. [ABSTRACT FROM AUTHOR]

Importance: Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the US Food and Drug Administration (FDA) has not been evaluated.Objectives: To characterize pivotal efficacy trials (clinical trials that serve as the basis of FDA approval) for newly approved novel therapeutic agents.Design and Setting: Cross-sectional analysis using publicly available FDA documents for all novel therapeutic agents approved between 2005 and 2012.Main Outcomes and Measures: Pivotal efficacy trials were classified according to the following design features: randomization, blinding, comparator, and trial end point. Surrogate outcomes were defined as any end point using a biomarker expected to predict clinical benefit. The number of patients, trial duration, and trial completion rates were also determined.Results: Between 2005 and 2012, the FDA approved 188 novel therapeutic agents for 206 indications on the basis of 448 pivotal efficacy trials. The median number of pivotal trials per indication was 2 (interquartile range, 1-2.5), although 74 indications (36.8%) were approved on the basis of a single pivotal trial. Nearly all trials were randomized (89.3% [95% CI, 86.4%-92.2%]), double-blinded (79.5% [95% CI, 75.7%-83.2%]), and used either an active or placebo comparator (87.1% [95% CI, 83.9%-90.2%]). The median number of patients enrolled per indication among all pivotal trials was 760 (interquartile range, 270-1550). At least 1 pivotal trial with a duration of 6 months or greater supported the approval of 68 indications (33.8% [95% CI, 27.2%-40.4%]). Pivotal trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 91 indications (45.3% [95% CI, 38.3%-52.2%]), clinical outcomes for 67 (33.3% [95% CI, 26.8%-39.9%]), and clinical scales for 36 (17.9% [95% CI, 12.6%-23.3%]). Trial features differed by therapeutic and indication characteristics, such as therapeutic area, expected length of treatment, orphan status, and accelerated approval.Conclusions and Relevance: The quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications. This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents. [ABSTRACT FROM AUTHOR]

IMPORTANCE There is a need to describe contemporary outcomes of surgical aortic valve replacement (AVR) as the population ages and transcatheter options emerge. OBJECTIVE To assess procedure rates and outcomes of surgical AVR over time. DESIGN, SETTING, AND PARTICIPANTS A serial cross-sectional cohort study of 82 755 924 Medicare fee-for-service beneficiaries undergoing AVR in the United States between 1999 and 2011. MAIN OUTCOMES AND MEASURES Procedure rates for surgical AVR alone and with coronary artery bypass graft (CABG) surgery, 30-day and 1-year mortality, and 30-day readmission rates. RESULTS The AVR procedure rate increased by 19 (95%CI, 19-20) procedures per 100 000 person-years over the 12-year period (P<.001), with an age-, sex-, and race-adjusted rate increase of 1.6%(95%CI, 1.0%-1.8%) per year. Mortality decreased at 30 days (absolute decrease, 3.4%; 95%CI, 3.0%-3.8%; adjusted annual decrease, 4.1%; 95%CI, 3.7%- 4.4%) per year and at 1 year (absolute decrease, 2.6%; 95%CI, 2.1%-3.2%; adjusted annual decrease, 2.5%; 95%CI, 2.3%-2.8%). Thirty-day all-cause readmission also decreased by 1.1% (95%CI, 0.9%-1.3%) per year. Aortic valve replacement with CABG surgery decreased, women and black patients had lower procedure and higher mortality rates, and mechanical prosethetic implants decreased, but 23.9%of patients 85 years and older continued to receive a mechanical prosthesis in 2011. CONCLUSIONS AND RELEVANCE Between 1999 and 2011, the rate of surgical AVR for elderly patients in the United States increased and outcomes improved substantially. Medicare data preclude the identification of the causes of the findings and the trends in procedure rates and outcomes cannot be causally linked. Nevertheless, the findings may be a useful benchmark for outcomes with surgical AVR for older patients eligible for surgery considering newer transcatheter treatments. [ABSTRACT FROM AUTHOR]

The article examines the association between hospital readmission and mortality rates for cardiac patients who were presented with clinical case of acute myocardial infarction, heart failure and pneumonia. It highlights the impact of quality of medical care provided by health care centers in resolving the risk associated with cardiac patients. The Centers for Medicare & Medicaid Services in the U.S. on the basis of a cohort analysis revealed that differences in performance of hospitals and diagnostic parameters implied by hospital were of immense use in determination of readmission rate and mortality rate of cardiac patients.

The article focuses on a study regarding the evaluation of readmission and timing among Medicare beneficiaries who are readmitted for heart failure (HF), acute myocardial infarction (MI) and pneumonia. It mentions that hospital readmissions report poor health care facility and states that the U.S. Centers for Medicare and Medicaid Services (CMS) has started public reporting of outcomes for improving the hospital care quality. The study reveals that 30-day readmissions were frequent throughout the month after rehospitalization for HF, MI and pneumonia. It also presents statistics which depict the readmission of patients.

The article discusses a study which examined changes in the rate of hospitalization due to heart failure (HF) and one-year mortality rate in fee-for-service Medicare beneficiaries in the U.S. from 1998 to 2008. HF hospitalization and mortality rates were analyzed nationally and by state or territory. The study found that the age, sex and race-adjusted HF hospitalization rate decreased to 2007 per 100,000 person-years in 2008 from 2845 in 1998. The lowest rate of decline was observed in African American men. Risk-adjusted one-year mortality dropped to 29.6% in 2008 compared with 31.7% in 1999. The study showed an increase in some comorbidities such as hypertension and renal dysfunction in patients hospitalized for HF.

The article discusses a study on outcomes of carotid stenting based on operator experience in the U.S. from 2005 to 2007. The study evaluated the link between outcomes and two variables of operator experience, namely, annual volume and experience at the time of the procedure among new operators who performed carotid stenting for the first time following a national coverage decision by the Centers for Medicare & Medicaid Services (CMS). Administrative data collected from fee-for-service Medicare beneficiaries aged 65 years old and above was used under the study. Higher 30-day mortality was observed among patients treated by operators with lower annual volumes and patients treated early during a new operator's experience.

The article discusses a study which examined the proportion of ST-elevation myocardial infarction (STEMI) patients who are transferred with a door-in to door-out (DIDO) time of 30 minutes or less and assessed patient factors linked with delays in DIDO time. It notes that the preferred method of reperfusion for STEMI patients is primary percutaneous coronary intervention (PCI). Results showed that median DIDO time was 68 minutes. Older age, female sex and off-hours presentation were some of the factors associated with a DIDO time greater than 30 minutes. The study also found that only .6% of patients with DIDO times greater than 30 minutes had an absolute contraindication to fibrinolysis.

The article discusses a study which investigated trends in and economic implications of the use of fibrates in the U.S. and Canada. The researchers also examined the relationship between differences in the availability and use of brand-name versus generic formulations of fenofibrate in both countries. The population-level, observational cohort study utilized IMS Health data from both countries between January 2002 and December 2009. It was found that there has been an increase in prescriptions for fibrates in the U.S., while prescriptions in Canada remained stable.

The article focuses on a study which evaluated the association between automated external defibrillators (AEDs) use and survival for in-hospital cardiac arrest. The researchers examined 11,695 hospitalized patients who experienced cardiac arrests between January 1, 2000 to August 26, 2008 at U.S. hospitals following the introduction of AEDs on general and hospital wards. Study results indicated that hospitalized patients with cardiac arrest and use of AED were not associated with improved survival.

The article discusses a study which described the temporal changes in length of stay, discharge disposition, and short-term outcomes among older U.S. patients hospitalized for heart failure. The observational study examined 6,955,461 Medicare fee-for-service hospitalizations for heart failure between 1993 and 2006. The researchers found that the mean length of stay decreased from 8.81 days to 6.33 days between 1993 and 2006. The importance of examining an episode of acute care during a standardized period of assessment is also highlighted by the study.

The article offers information on a study which determined the link between lack of health insurance and financial concerns about accessing care among those with health insurance, and the time from symptom onset to hospital presentation during acute myocardial infarction (AMI). Data analyzed by researchers were from a registry of AMI patients enrolled between April 11, 2005 and December 31, 2008 at 24 U.S. hospitals. Medical records were utilized to determine insurance information, while information on financial concerns was taken from structured interviews. A detailed discussion on the research findings is presented.

The article focuses on a study which was designed to characterize the attitudes, experiences and training expectations of general surgery residents in the U.S. The study included a survey of all general surgery residents and was conducted after the American Board of Surgery In-Training Examination. Most of the study subjects claimed that they are satisfied with training and supportive peer relationships. However, there are residents who reported unmet needs and apprehensions related to training and careers. Study authors concluded that the attitude, experiences and training expectations of general surgery residents reflect high levels of satisfaction.

The article focuses on a study which estimated the racial differences in survival for patients with in-hospital cardiac arrests. The study also examined the link between sociodemographic and clinical factors, and admitting hospital. It included 10,011 patients diagnosed with cardiac arrests due to ventricular fibrillation or pulseless ventricular tachycardia. Such patients were from 274 hospitals within the National Registry of Cardiopulmonary Resuscitation. Study authors found that rates of survival to discharge are lower in black patients compared to white patients. They concluded that the racial difference in survival rates was associated with hospital center.

The article focuses on an observational study which estimated hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with acute myocardial infarction (AMI). Administrative data and a validated risk model were used to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the U.S. between January 1, 1995 to December 31, 2006. A significant decrease was observed in the risk-standardized hospital mortality rate for Medicare patients discharged with AMI, as well as between-hospital variation.

The article presents research assessing the association of implanting physician certification with outcomes following implantable cardioverter-defibrillator (ICD) procedures. The design and setting of the study involving cases submitted to the ICD Registry and analysis of certification status of the implanting physicians into categories of electrophysiologists, nonelectrophysiologists, cardiologists, and thoracic surgeons is explained. The medical outcomes measured were in-hospital procedural complication rates and the likelihood of receiving cardiac resynchronization therapy (CRT-D). Results indicate implantation by nonelectrophysiologists is associated with a higher risk of complications and a lower rate of CRT-D.

Context: While glucose control is recommended by professional societies for patients with hyperglycemia hospitalized with acute myocardial infarction (AMI), enthusiasm for glucose lowering is tempered, in part, by concerns of inducing hypoglycemia. Yet, whether episodic hypoglycemia that occurs as a result of glucose-lowering therapy is harmful in patients with AMI is unknown.Objective: To determine whether the mortality risk associated with hypoglycemic events is similar in patients who develop hypoglycemia spontaneously and those who develop it as a result of insulin therapy.Design, Setting, and Patients: Retrospective cohort study using data from Health Facts, a contemporary database of patients hospitalized across the United States in 40 hospitals between January 1, 2000, and December 31, 2005. Of all the patients in the database, 7820 patients were hospitalized with AMI and were hyperglycemic on admission (glucose level > or = 140 mg/dL). Patients were stratified based on whether they developed a hypoglycemic event (random glucose level < 60 mg/dL) during subsequent hospitalization. Logistic regression models were used to evaluate the association between hypoglycemia and in-hospital mortality within subgroups of patients who were and were not treated with insulin therapy.Main Outcome Measure: All-cause in-hospital mortality.Results: Among patients treated or not treated with insulin, those with hypoglycemia were older and had more comorbidity. Hypoglycemia was associated with increased mortality in patients not treated with insulin (18.4% [25/136] mortality in patients with hypoglycemia vs 9.2% [425/4639] in those without hypoglycemia; P<.001), but not in those treated with insulin (10.4% [36/346] mortality in patients with hypoglycemia vs 10.2% [276/2699] in those without hypoglycemia; P = .92). After multivariable adjustment, there was a significant interaction between hypoglycemia and insulin therapy (P value for interaction = .01). Hypoglycemia was a predictor of higher mortality in patients who were not treated with insulin (odds ratio, 2.32 [95% confidence interval, 1.31-4.12] vs patients without hypoglycemia), but not in patients treated with insulin (odds ratio, 0.92 [95% confidence interval, 0.58-1.45] vs patients without hypoglycemia).Conclusions: While hypoglycemia was associated with increased mortality in patients with AMI, this risk was confined to patients who developed hypoglycemia spontaneously. In contrast, iatrogenic hypoglycemia after insulin therapy was not associated with higher mortality risk. [ABSTRACT FROM AUTHOR]

The article reports on the results of research which was conducted in an effort to determine whether the mortality risk associated with hypoglycemic events is similar in patients who develop hypoglycemia spontaneously and those who develop it as a result of insulin therapy. Researchers used a retrospective cohort study which used data from Health Facts, a database of patients hospitalized across the U.S. They found that while hypoglycemia was associated with increased mortality in patients with acute myocardial infarction, this risk was confined to patients who developed hypoglycemia spontaneously. They also found that iatrogenic hypoglycemia after insulin therapy was not associated with higher mortality risk.

Context: Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.Objective: To characterize different types and the extent of guest authorship and ghostwriting in 1 case study.Data Sources: Court documents originally obtained during litigation related to rofecoxib against Merck & Co Inc. Documents were created predominantly between 1996 and 2004. In addition, publicly available articles related to rofecoxib identified via MEDLINE.Data Extraction: All documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or ghostwriting.Data Synthesis: Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company.Conclusions: This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support. [ABSTRACT FROM AUTHOR]

The article presents the results of a literature review conducted by the authors that examined the putative genetic risk factors for acute coronary syndromes. The authors genotyped white patients with acute coronary syndromes and controls for variants in genes in an attempt to duplicate associations of the genetic variants with risk factors for acute coronary syndromes that had previously been reported. The authors found that none of the genetic variants tested were risk factors for acute coronary syndromes. The authors state that the previously reported studies linking the genetic variations to acute coronary syndromes need to be replicated before their findings are put into clinical practice.

Context: Recent legislation in 5 states and the District of Columbia mandated state disclosure of payments made to physicians by pharmaceutical companies. In 2 of these states, Vermont and Minnesota, payment disclosures are publicly available.Objectives: To determine the accessibility and quality of the data available in Vermont and Minnesota and to describe the prevalence and magnitude of disclosed payments.Design and Setting: Cross-sectional analysis of publicly available data from July 1, 2002, through June 30, 2004, in Vermont and from January 1, 2002, through December 31, 2004, in Minnesota.Main Outcome Measures: Accessibility and quality of disclosure data and the number, value, and type of payments of $100 or more to physicians.Results: Access to payment data required extensive negotiation with the Office of the Vermont Attorney General and manual photocopying of individual disclosure forms at Minnesota's State Board of Pharmacy. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years. In Vermont, among 12,227 payments totaling $2.18 million publicly disclosed, there were 2416 payments of $100 or more to physicians; total, $1.01 million; median payment, $177 (range, $100-$20,000). In Minnesota, among 6946 payments totaling $30.96 million publicly disclosed, there were 6238 payments of $100 or more to physicians; total, $22.39 million; median payment, $1000 (range, $100-$922,239). Physician-specific analyses were possible only in Minnesota, identifying 2388 distinct physicians who received payment of $100 or more; median number of payments received, 1 (range, 1-88) and the median amount received, $1000 (range, $100-$1,178,203).Conclusions: The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed. However, substantial numbers of payments of $100 or more were made to physicians by pharmaceutical companies. [ABSTRACT FROM AUTHOR]

The article presents a medical research study that examined self-reported financial barriers to medical care services or medication in patients with acute myocardial infarction. Data was achieved through the Prospective Registry Evaluating Myocardial Infarction: Event and Recovery study. The health status symptoms, overall health status function, and rehospitalization rates of the patients were measured. The authors found that financial barriers to health care services and medications are associated with worse recovery after acute myocardial function, as evidenced by more angina, a poorer quality of life, and a greater risk of rehospitalization.

The article presents a research study that examined whether the opening of specialty cardiac hospitals was associated with increased population-based rates of coronary revascularization in Medicare beneficiaries. The authors calculated annual population-based rates of total revascularization, which was broken down into coronary artery bypass graft (CABG) plus percutaneous coronary intervention (PCI), CABG, and PCI. The authors used hospital referral regions to categorize health care markets into those where cardiac hospitals opened, new cardiac programs opened in general hospitals, and no new programs opened. The authors conclude that the opening of a cardiac hospital within a hospital referral region increased population-based rates of coronary revascularization in Medicare beneficiaries. [ABSTRACT FROM AUTHOR]

This JAMA Guide to Statistics and Methods summarizes latent class analysis, a statistical technique that estimates the probability of patients belonging to a discrete group that shares specific combinations of observed variables, and explains how the technique is used and can be interpreted in observational research. [ABSTRACT FROM AUTHOR]

The article presents the results of a statistical study which used the Surveillance, Epidemiology and End Results Medicare database to determine the impact of increased Medicare coverage for colonoscopy screening on the early detection of colon cancer among patients over age 67. The medical information of over 44,000 patients was included in the sample. Medicare's reimbursement policy was widened in 1998, and again in 2001. The expanded coverage was found to have increased the use of colonoscopies, and clearly improved the subjects' chances for early diagnosis of proximal colon lesions. Details of the methodology and results are provided.

The article discusses the underrepresentation of chronic renal disease in randomized controlled trials of cardiovascular disease. Nine million people in the United States population have chronic kidney disease. And of these many have cardiovascular disease (CVD), specifically coronary artery disease and chronic congestive heart failure. Recent studies suggest that renal disease independently portends increased morbidity and mortality in CVD. Because renal disease is so prevalent in CVD and the pathophysiologic processes so different from those with normal renal functions, it is important to have data on the subgroup of renal diseases. Patients with renal diseases must not be excluded, but included in CVD trials which need to be designated for this population of chronic renal patients.

Context: The Centers for Medicare & Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) measure and report quality process measures for acute myocardial infarction (AMI), but little is known about how these measures are correlated with each other and the degree to which inferences about a hospital's outcomes can be made from its performance on publicly reported processes.Objective: To determine correlations among AMI core process measures and the degree to which they explain the variation in hospital-specific, risk-standardized, 30-day mortality rates.Design, Setting, and Participants: We assessed hospital performance in the CMS/JCAHO AMI core process measures using 2002-2003 data from 962 hospitals participating in the National Registry of Myocardial Infarction (NRMI) and correlated these measures with each other and with hospital-level, risk-standardized, 30-day mortality rates derived from Medicare claims data.Main Outcome Measures: Hospital performance on AMI core measures; hospital-specific, risk-standardized, 30-day mortality rates for AMI patients aged 66 years or older.Results: We found moderately strong correlations (correlation coefficients > or =0.40; P values <.001) for all pairwise comparisons between beta-blocker use at admission and discharge, aspirin use at admission and discharge, and angiotensin-converting enzyme inhibitor use, and weaker, but statistically significant, correlations between these medication measures and smoking cessation counseling and time to reperfusion therapy measures (correlation coefficients <0.40; P values <.001). Some process measures were significantly correlated with risk-standardized, 30-day mortality rates (P values <.001) but together explained only 6.0% of hospital-level variation in risk-standardized, 30-day mortality rates for patients with AMI.Conclusions: The publicly reported AMI process measures capture a small proportion of the variation in hospitals' risk-standardized short-term mortality rates. Multiple measures that reflect a variety of processes and also outcomes, such as risk-standardized mortality rates, are needed to more fully characterize hospital performance. [ABSTRACT FROM AUTHOR]

The study examined whether blinded peer review affected abstract acceptance rates submitted for a research meeting. During the period 2000-2004, the study examined abstracts submitted to the American Heart Association for the annual Scientific Session meeting. Abstracts that were reviewed from 2000-2001 included the name of the author and their affiliation; from 2002-2004, abstracts were reviewed using blinded review, which hid this basic information about the author. Abstract submissions were categorized by country of origin, institutional prestige, sex of the author, primary language, and government and industry relationships of the authors. The study concluded that bias exists in the open review of abstracts. Blinded abstract submission somewhat reduced bias, but did not eliminate bias altogether.